Dhanashri Bhoite
Pune
Summary
- Organized and dependable candidate successful at managing multiple priorities with a positive attitude.
- Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills.
- Ability to handle multiple projects simultaneously with a high degree of accuracy.
- Effective leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency.
- Highly committed with hardworking mentality to maintain quality of services and products.
Overview
17
17
years of professional experience
Work History
Senior Executive Quality Control
Centaur Pharmaceuticals Pvt. Ltd. (USFDA, MHRA Approved OSD)
Pune
06.2015 - Current
- Group leader of team of 22 team members handling the activities of QC Analytical data and electronic data Review for batch release and compliance, Regulatory audits, Instrumentation, LIMS, Investigation, Documentation (SOP, Specifications, Protocol /Reports)
- Handled projects of Analytical method Validations, verifications and methid transfers
- Method development and validation for impurities by ICPMS and LC HRMS
- Handling of Regulatory audits of USFDA, MHRA, LaGeSo, Health Canada, Russia and client audits
- Involved in the compliance and third party assessments for Regatory audits
- Hands on experience for Investigations and qualifications of analytical instruments
- Implementation of software's such as LIMS, eDMS, eQMS
- Expertise on handling of QMS documents as Change control, CAPA, Deviations, OOS, OOT and other laboratory investigations
- Review and execution of method validation, verification and transfer activities, gap assessments
- Pharmacopoeial updates implementation
- Qualification and maintenance of Working standards, reference standards, columns
Lab Manager
MAARC Labs Pvt. Ltd. (NABL, BIS, Coca Cola, FSSAI Approved CTL)
Pune
08.2011 - 06.2015
- Responsible for Planning of analysis of different types of raw materials, finished products and water samples for chemical analysis
- Handled Audits of NABL, BIS and customer audits
- Responsible for handling of method validations using GC, HPLC, LCMS and GC MS
- Responsible for handling QMS documents and training
Research Assistant
Intox Pvt. Ltd. (Toxicological Research Institute)
Pune
01.2010 - 10.2010
- Assistance in method development and validations of technical substances and formulations for different types of toxicological studies
- Preparation of method validation protocols and reports
- Calibration of instruments and analysis of samples for toxicological studies
Analyst
MAARC Labs Pvt. Ltd.
Pune
02.2008 - 12.2009
- Analysis of raw materials and finished products
- Calibration of Analytical instruments
- Preparation of COA and reports
Trainee and Jr. Officer
Indoco Remedies Pvt. Ltd. (R&D Centre Of API)
Mumbai
12.2006 - 12.2007
- Chemical and instrumental analysis of Raw materials, intermediate and API
- Calibrations of Analytical instruments
- Method development and validation of particle size by Malvern Mastersizer
- Documentation of Technical transfer packages and specifications
Education
PG Program In Data Science And Business Analytics - Data Science
Great Learning Lakes Institute
Distance LearningMasters Of Science - Chemistry
Vinayaka Mission University
Mumbai06.2017
PG Diploma In Food, Drug And Cosmetic Analysis - Specialization in Analysis of Food, Drugs And Cosmetics
Veermata Jjjabai Technological Institute
Mumbai06.2007
Bachelor Of Science - Chemistry
S. P. College
Pune06.2005
Skills
- Project Planning
- Analytical and Critical Thinking
- Excellent Communication
- Teamwork and Collaboration
- Relationship Building
- Interpersonal Communication
- Task Prioritization
- Team Management
Timeline
Senior Executive Quality Control
Centaur Pharmaceuticals Pvt. Ltd. (USFDA, MHRA Approved OSD)
06.2015 - Current
Lab Manager
MAARC Labs Pvt. Ltd. (NABL, BIS, Coca Cola, FSSAI Approved CTL)
08.2011 - 06.2015
Research Assistant
Intox Pvt. Ltd. (Toxicological Research Institute)
01.2010 - 10.2010
Analyst
MAARC Labs Pvt. Ltd.
02.2008 - 12.2009
Trainee and Jr. Officer
Indoco Remedies Pvt. Ltd. (R&D Centre Of API)
12.2006 - 12.2007
PG Program In Data Science And Business Analytics - Data Science
Great Learning Lakes Institute
Masters Of Science - Chemistry
Vinayaka Mission University
PG Diploma In Food, Drug And Cosmetic Analysis - Specialization in Analysis of Food, Drugs And Cosmetics
Veermata Jjjabai Technological Institute
Bachelor Of Science - Chemistry
S. P. College